Surgical scalpels are regularly used by surgeons and other health care professionals for making incisions, as well as for other purposes, when a sharp instrument is required.
During routine surgical procedures, the operating room assistant (which may be a nurse or another doctor) has to "slap" the scalpel into the surgeon's hand. This must be done so that the surgeon can "feel" the scalpel's orientation, thereby permitting the surgeon to automatically grip the handle of the scalpel without taking his or her eyes away from the patient or operatory field. Because the surgeon does not remove his or her eyes from the operatory field, the surgeon is unable to see if the scalpel is being handed to him or her with the handle or blade of the scalpel in the palm of his or her hand. This can cause the surgeon's hand to be cut, thereby causing blood or body fluid exposure from the doctor to the patient and vice-versa. Moreover, when handing the scalpel back to the assistant, the surgeon is often unable to properly orient the scalpel. Thus, the assistant is often required to take the scalpel from the surgeon by gripping either the blade of the scalpel or a part of the scalpel that is in close proximity to the blade.
In both of the above cases, it is not uncommon for the surgeon's assistant, and sometimes even the surgeon, to be cut by the blade of the scalpel. Such cuts, in addition to being rather uncomfortable, can lead to the spreading of infection and disease. Concern over this situation has become especially acute since the appearance of the human immune deficiency virus (or "HIV"). Indeed, such cuts have already been blamed, by some health care providers, for cases of HIV infection in their profession. Consequently, some individual surgeons or health care providers have gone so far as to stop performing surgical operations altogether, rather than risk the chances of inadvertently contracting the deadly HIV from an infected patient.
Similar concerns are related to the Hepatitus B virus (or "HBV").
The risks associated with scalpel cuts during an operating room procedure are greater than those associated with needle sticks; but even there, the problem is becoming alarming. In a study made by the Needle Stick Surveillance Group of the C.D.C. (Communicable Disease Center) out of 3,978 known punctures from patients known to be HIV positive, 13 health care workers got infected or roughly 1 out of 300. Thus, from a single needle stick while treating an AIDS patient in an operating room or other environment, the chances are roughly 1 out of 300 that the surgeon, nurse or other individual health care provider will sero-convert and become HIV positive.
If a surgeon, nurse or assistant is cut by a scalpel while conducting a surgical procedure in an operating room (rather than a needle stick) the risk is much greater simply because, first, there is more blood involved and, secondly, the surface area of the wound produced is larger. In operating on an HIV positive patient, and even if the chances of becoming HIV positive from a scalpel cut are substantially the same as the needle sticks--roughly 1 out of 300-if the surgeon or nurse performs just one operating room procedure on an HIV-positive patient per day for 6 days a week, 50 weeks per year, then the chances of becoming HIV positive through an inadvertent cut in an operating room procedure are virtually guaranteed!
This situation has become so pronounced that some leading surgeons, as well as nurses and other individual health care providers, have abandoned their respective practices.
While protective gloves aid in reducing the chances of being cut during a surgical procedure, these gloves are by no means foolproof, and such cuts are still quite common. Even when two sets of gloves are utilized, full protection is not afforded to the health care provider, for many times the blade cuts right through both sets of gloves. Also, utilizing two sets of gloves at the same time reduces finger dexterity, thereby presenting problems during the intended surgical procedure and tending to reduce the effectivity thereof.
There have been numerous disclosures for providing protective blade guards for surgical scalpels which prevent inadvertent contact with the surgical blade prior to introduction of the scalpel into the sterile field where it will be used. Once the scalpel is in the sterile field, however, the protective blade guard is removed until the surgical procedure is finished. Examples of such disclosures (of which we are aware) are as follows:
______________________________________ Inventor(s) Patent No. ______________________________________ Leopoldi 3,706,106 Porat, et al. 4,719,915 Williams 4,735,202 Chase, et al. 4,825,545 Lipton 4,985,034 Baskas 5,035,703. ______________________________________
While these arrangements are useful for their intended purposes, none are readily adaptable for use during a surgical procedure in an operating room. In each of these devices, the protective blade guard is often a separate piece from the remainder of the scalpel. Thus, when using of the scalpel during the surgical procedure, the protective blade guard must be removed entirely therefrom. Such an arrangement requires a two-handed operation for the removal (and possibly the replacement) of the protective blade guard. One hand is necessary to grip the scalpel while the other hand is used to grip the guard. As such, these protective surgical blade guards are not practical for use during a standard surgical procedure in an operating room or equivalent area.
Preferably, a blade guard for a surgical scalpel should meet the following criteria:
(1) the protective guard should be retracted to expose the blade and, thereafter, advanced to cover the blade with the use of only one hand:
(2) the protective blade guard should be actively and solidly fixed (positively locked) in the position selected, so that the protective blade guard will not be accidentally dislodged or moved as a result of the necessary pressure that is exerted on the scalpel by the surgeon during the operating procedure;
(3) the doctor (or other user of the scalpel) must be able to readily and tactually identify the mechanism or element which permits (or releases) the protective blade guard to be moved, so that the protective blade guard can be placed in the selected position desired without the user thereof having to remove his or her eyes from the patient in order to visually observe the scalpel;
(4) the shape of the protective blade guard of the scalpel should substantially approximate the shape of the body of the scalpel by which the guard is carried, so that during use of the scalpel, the user may utilize a grip that substantially approximates the grip that is normally utilized, thereby providing the user with a good and comfortable "feel" when performing the surgical operating procedure; and
(5) the scalpel should provide an auditory sensory means, whereby the user may be made aware that the protective blade guard has actually been locked into a desired selected position without the necessity of having to remove his or her eyes from the patient in order to visually observe the scalpel.
In U.S. Pat. Nos. 4,516,575 issued to Gerhard, et al., and 4,499,898 issued to Knepshield, et al., microsurgical scalpels designed for use in opthalmic surgery are disclosed wherein the surgical blade itself is movable in and out of the body of the scalpel. This is intended to control the depth of the incision in opthalmic surgery. While helping to give the surgeon a comfortable grip, neither of these devices meets the other requirements noted above for providing a guarded scalpel that is readily usable in standard operating procedures. In each of these scalpels, extension and retraction of the surgical blade is a two-handed operation, one hand being needed to hold the stationary part of the scalpel, and the second hand being needed to rotate the mechanism that moves the surgical cutting blade into a selected position desired. As noted above, such a two-handed operation makes these devices unadaptable for use in standard surgical procedures. Further, during use, pressure is placed on the surgical blade, which can result in accidental dislodgement or movement of the blade during the surgical procedure, a quite undesirable occurrence. Finally, it is noted that there is no auditory or tactile means whatsoever provided which would either identify the mechanism which permits the user to selectively position the surgical cutting blade or which would signal or indicate to a user that the blade is in the position desired without having to remove his or her eyes from the patient in order to visually observe the scalpel.
In U.S. Pat. No. 4,414,974 issued to Dotson. et al. a microsurgical knife is disclosed having a slidable shroud that can be moved into a forward position to protect the blade and rearwardly to allow use of the knife. However, this device is problematic in that no structures are provided thereon which fixedly and solidly retain and positively lock the shroud in place. Rather, the shroud is held in place only by reliance on a wedged fit. Since the shroud covers the body of the scalpel, during use of the scalpel in a standard surgical procedure, the shroud itself would be gripped by the user and pressure exerted directly thereon. Thus, the shroud of that device is readily susceptible to becoming accidentally dislodged or moved as a result of ordinary pressure being exerted thereon by the user during a surgical procedure. Furthermore, Dotson et al, requires a definite effort to move the shroud forwardly. As such, like the disclosures discussed above, this arrangement can require the user thereof to utilize two hands for moving the shroud, a situation which is not always possible nor desirable in an operating room ("O.R.").
In the O.R., time is of the essence and seconds count; the mental concentration and physical effort are intense; and distractions must be avoided at all times.
Finally, in U.S. Pat. No. 4,576,164 issued to Richeson, a microsurgical knife is disclosed which attempts to remedy the problems associated with Dotson et al by providing an arrangement for locking the sheath. While achieving this, locking the shroud of Richeson i place nonetheless involves a two-handed operation. One hand must hold the shroud, and the other must grip the body of the scalpel in order to effect the twisting motion necessary to lock the shroud. Hence, like many of the other disclosures, the scalpel of Richeson is not readily adaptable for use in operating room procedures. Further, there are no auditory or sensory means whatsoever provided in that arrangement which would permit the user thereof to be made aware that the protective blade guard has actually been locked into the selected position without having to remove his or her eyes from the patient in order to visually observe the scalpel.
Thus, it can be seen that there remains a need for a surgical scalpel that has a protective blade guard which is readily adaptable for use during a variety of surgical procedures in a standard operating room, and which meets the objectives and desired criteria noted above.